Present treatment modalities (i.e., highly active anti-retroviral therapies or HAART) for patients diagnosed with HIV have progressed to the extent that many patients have extremely low or undetectable levels of virus in their plasma, i.e., they are aviremic. However, in most cases, once the patient stops taking their medications (takes a “drug holiday”), the virus rebounds and a resurgence of viral replication is seen. This indicates that, while there may be no detectable levels of virus in the plasma in well-controlled patients, a reservoir of replication-competent virus still exists. Furthermore, even in patients who are well-suppressed, i.e., who have fewer than 40 or 50 copies/mL of plasma viral RNA, episomal infection intermediates, 2-LTR circles, can usually be detected, indicating ongoing cryptic or covert replication. See, e.g., U.S. Pat. Nos. 7,232,657 and 6,797,464; and U.S. Pat. Pub. No. 2005-0064393.
New treatment methods have been developed, referred to as “intensified HAART,” in which newly-developed drugs, e.g., drugs targeting the viral receptors or the viral integration process, are added to a HAART regimen in an attempt to achieve complete viral eradication.